Promicef Tazo (Ceftriaxone)

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Description

COMPOSITION:

Each combipack contains:

(a) 1 Vial of Ceftriaxone & Tazobactam for Injection Each vial contains:

Ceftriaxone Sodium IP (Sterile)     Eq. to Anhydrous Ceftriaxone        500 mg

Tazobactam Sodium IP (Sterile) Eq. to Tazobactam                             62.5 mg

(b) 1 Ampoule of Sterile Water for Injections IP

Each Ampoule Contains:   Sterile Water for Injections IP 5 ml

 

DESCRIPTION

Ceftriaxone sodium is a white to yellowish crystalline powder and Tazobactam sodium is a white crystalline powder, both are readily soluble in water. Each vial contains ceftriaxone sodium equivalent to 500 mg of ceftriaxone activity and tazobactam sodium equivalent 62.5 mg of tazobactam activity.

CLINICAL PHARMACOLOGY

Ceftriaxone

Ceftriaxone is a third-generation beta-lactam antibiotic from the cephalosporin group. Ceftriaxone selectively and irreversibly inhibits bacterial cell wall synthesis by binding to transpeptidases, which are penicillin-binding proteins (PBPs) that catalyze the cross-linking of the peptidoglycan polymers forming the bacterial cell wall. The peptidoglycan cross-linking activity of PBPs is a construction and repair mechanism that normally helps to maintain bacterial cell wall integrity, so the inhibition of PBPs leads to damage and destruction of the cell wall and eventually

Ceftriaxone is effective against both Gram-positive and Gram negative bacteria. Gram-positive susceptibility includes certain Staphylococcus and Streptococcus organisms.

Gram-negative susceptibility includes Bacteroides spp.

Enterobacter spp. E. coll, Klebsiella spp, Proteus spp.

Pseudomonas aerogenosa and Serratia spp.

Ceftriaxone is not absorbed after oral administration and must be given parenterally, It is widely distributed throughout the body, CSF levels are higher when meninges are inflamed.

Ceftriaxone crosses the placenta and enters maternal milk in low concentrations. Ceftriaxone is excreted by both renal and non-renal mechanisms. In dogs, ceftriaxone bioavailability after IM administration equal that of IV, but peak levels occur much faster after IM (approx. 30 minutes) total area under the curve is similar for IM routes. Elimination half-life is longer after IM (1.17 hrs) than IV administration (0.88 hrs).

Tazobactam

Tazobactam is a penicillanic acid sulfone derivative with beta-lactamase inhibitory properties. It enhances the activity of beta-lactam antibacterials against beta-lactamase-producing bacteria.

The beta-lactamase inhibitors are a specific class of drugs with little antibacterial effects of their own, but they act to inhibit beta-lactamase enzyme.

INDICATIONS

PROMICEF TAZO injection is indicated for the treatment of the following infections caused by beta-lactam antibacterial resistant organisms in dogs and cats: Respiratory tract infections, Bacterial dermatological infections, Urinary tract infections, Bone & Joint Infection, Bacterial septicemia, Intra-abdomínal infection, Meningitis and other systemic bacterial infections.

DOSAGE AND ADMINISTRATION

In dogs, the usual dose is 15 to 50 mg/kg every 12 to 24 hours intramuscularty or intravenously.

In cats, the usual dose is 25 to 50 mg/kg every 12 hours intramuscularly or intravenously.

Ceftriaxone & Tazobactam dose is based on equivalent of ceftriaxone dose (Ceftriaxone 500mg is

equivalent to

Ceftriaxone and Tazobactam for Injection 562.5 mg).

The dose and duration: The duration of administration depends on the condition being treated, response to the medication, and / or as directed by your veterinarian.

DIRECTION FOR USE

Dissolve the contents in 5 ml of Sterile Water for Injections IP for IV use, 2 ml of Sterile water for injections IP for IM use. The constituted solution should be used immediately after preparation.

WARNINGS AND PRECAUTIONS

PROMICEF TAZO should not be used in dogs and cats with known hypersensitivity or allergy to ceftriaxone/tazobactam

PROMICEF TAZO injection is not for oral use. For IV / IM use in dogs and cats.

Keep medicine out of reach of children.

PREGNANCY AND LACTATION SAFETY

No teratogenic effects were demonstrated in reported studies in pregnant mice and rats given up to 20X labeled dose of ceftriaxone. No such study reported for tazobactam.

Ceftriaxone/Tazobactam is distributed into milk in low concentrations and is unlikely to pose risk to nursing offspring of dogs and cats.

ADVERSE REACTIONS

Ceftriaxone Induced Steven-Johnson Syndrome (SJS).

Nausea, vomiting and diarrhea may occasionally be seen.

Increased serum concentrations of liver enzymes, BUN, creatinine and urine casts may occur following treatment with ceftriaxone/tazobactam. A false-positive Coombs' test and false-positive urine glucose may occur.

Hematological side effects like eosinophilia, thrombocytosis and leucopoenia may or may not be observed following treatment with ceftriaxone/tazobactam.

Intramuscular injections can be painful, and repeated

Intravenous administration may lead to local phlebitis.

DRUG INTERACTIONS

Parenteral aminoglycoside and cephalosporins should not be

used concurrently,

Concomitant use with calcium containing solutions should be avoided.

STORAGE

Store below 30°C. Protect from light & moisture.

Do not freeze.

PRESENTATION

500 mg Ceftriaxone and 62.5 mg of Tazobactam in powder form.

5 ml sterile water for injection.

562.5 mg Vial with WFI

Dosage:
15 to 25 mg/kg
every 24 hours through IM,
SC or IV administration
in dogs & cats

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